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The goal of this prospective cohort study is to investigate long-term therapeutic strategies for myasthenia gravis (MG) and identify potential biomarkers. The main questions it aims to answer are:
This study recruits well-controlled patients with MG. Based on patient preferences and considerations such as coexisting conditions (e.g., uncontrolled hypertension, diabetes, severe osteoporosis, obesity), the participants will be non-randomly divided into two groups: a maintenance steroid therapy group and a withdrawal group (withdraw all immunosuppresants). Subsequently, these groups of patients will undergo long-term follow-up assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| maintenance steroid therapy group | Maintaining low-dose oral steroids |
| |
| immunosuppresants withdrawal group | Withdraw all immunosuppresants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid Drug | Drug | Maintaining low-dose oral steroids |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse of myasthenia gravis | One of the following three is met: (1) MGFA Postintervention Status: failure to maintain MMS (minimal manifestations status) or better. (2) Myasthenia gravis activities of daily living (MG-ADL) score ≥ 3; (3) Re-administration of cholinesterase inhibitors was required after achieving Complete Stable Remission (CSR) on the MGFA Postintervention Status. | Within two years after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Time of relapse | The time between recruitment and relapse of MG. | Within two years after recruitment |
| Change of MG assessment scales at relapse | Change of MG assessment scales at relapse, including MGFA PIS (Postintervention Status), MG-ADL (myasthenia gravis activities of daily living), QMG (Quantitative Myasthenia gravis) and MGC (Myasthenia gravis composite). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with myasthenia gravis who can completed long-term follow-up at PUMCH.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuzhou Guan | Contact | 8610-69155817 | guanyz001@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yuzhou Guan | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Whole blood of each participant at each visit.
| Withdraw all immunosuppresants |
| Other |
Withdraw all immunosuppresants |
|
| Within two years after recruitment |
| Adverse events of steroids | Using CTCAE (Common Terminology Criteria for Adverse Events) to assess Adverse events. | Within two years after recruitment |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |